In February, the Environmental Protection Agency (EPA) issued a Notice of Data Availability (NODA) seeking information on ways to more effectively regulate hazardous waste—including pharmaceuticals—in the retail sector under the Resource Conservation and Recovery Act (RCRA). The healthcare industry has already submitted comments expressing concern that EPA may modify the “reverse distribution” system currently in place for disposal of outdated or unsold pharmaceuticals. Under the reverse distribution system, retailers send expired and unsold pharmaceuticals to a central reverse distributor and receive financial credit for returned product from the drug manufacturer. The pharmaceuticals are then appropriately disposed of under RCRA. EPA currently takes the position that reverse distribution systems do not trigger RCRA regulation until the credit determination is made. However, EPA’s proposed rule—expected this August—could require pharmacies and retailers to make RCRA hazardous waste determinations, and obtain the proper means of hazardous waste disposal for pharmaceuticals, thereby eliminating the role of reverse distributors for hazardous waste pharmaceuticals. 

Some states are already moving this direction – restricting the use of the reverse distribution system for outdated drugs and requiring retails stores to manage the waste under RCRA. Not only does retail-level regulation eliminate credits for returned hazardous waste pharmaceuticals, it places a rather complicated compliance burden on tens of thousands of pharmacies with no experience in hazardous waste disposal. Further, DEA regulations are expected in the next few months that will restructure existing regulations concerning disposal of controlled substances, including those applicable to reverse distributors. These regulations are expected to enable the collection and disposal of controlled substances through DEA-authorized collectors, much like the centralized reverse distribution system at issue in EPA’s upcoming rulemaking. We may see starkly different approaches for non-hazardous pharmaceuticals (which could continue to be sent to reverse distributors), hazardous waste pharmaceuticals and controlled substances, which would likely create additional confusion for retail pharmacies. 

EPA will continue to take comments until May 30.